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CTRI Number  CTRI/2018/02/012105 [Registered on: 23/02/2018] Trial Registered Prospectively
Last Modified On: 12/02/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Yoga on Obstructive Sleep Apnea (OSA) 
Scientific Title of Study   Effect of yoga on health-related status and cardiovascular risk factors among obstructive sleep apnoea patients: A Multi-Centric Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gautam Sharma 
Designation  Professor, Cardiology and Professor In-charge, Center of Integrative Medicine and Research (CIMR)  
Affiliation  Centre of Integrative Medicine and Research (CIMR) 
Address  Centre of Integrative Medicine and Research (CIMR) Convergence Block, All India Institute of Medical Sciences (AIIMS) New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  drsharmagautam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gautam Sharma 
Designation  Professor, Cardiology and Professor In-charge, Center of Integrative Medicine and Research (CIMR)  
Affiliation  Centre of Integrative Medicine and Research (CIMR) 
Address  Centre of Integrative Medicine and Research (CIMR) Convergence Block, All India Institute of Medical Sciences (AIIMS) New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  drsharmagautam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gautam Sharma 
Designation  Professor, Cardiology and Professor In-charge, Center of Integrative Medicine and Research (CIMR)  
Affiliation  Centre of Integrative Medicine and Research (CIMR) 
Address  Centre of Integrative Medicine and Research (CIMR) Convergence Block, All India Institute of Medical Sciences (AIIMS) New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  drsharmagautam@gmail.com  
 
Source of Monetary or Material Support  
Centre of Integrative Medicine and Research (CIMR) Convergence Block, All India Institute of Medical Sciences (AIIMS) New Delhi 
 
Primary Sponsor  
Name  Ministry of AYUSH 
Address  Centre of Integrative Medicine and Research (CIMR) Convergence Block, All India Institute of Medical Sciences (AIIMS) New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
GAUTAM SHARMA  All India Institute of Medical Sciences (AIIMS)  Room number 7004 and 7001 Centre of Integrative Medicine and Research (CIMR) Convergence Block, All India Institute of Medical Sciences (AIIMS) New Delhi
South
DELHI 
01126549326

drsharmagautam@gmail.com 
BISHAV MOHAN  DAYANAND MEDICAL COLLEGE AND HOSPITAL  DAYANAND MEDICAL COLLEGE AND HOSPITAL Tagore Nagar, Civil Lines, Ludhiana, Punjab 141001
Ludhiana
PUNJAB 
9876741158

bishav_68@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
AIIMS IEC  Submittted/Under Review 
DMCH IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  OBSTRUCTIVE SLEEP APNEA,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  The patients in the control group will continue to receive the standard medical treatment along with advice on life style modification and dietary changes. Interested candidates will be taught yoga after the completion of the study.  
Intervention  Yoga with standard of care group  The intervention group will be taught yoga practices by institutionally trained yoga therapist (as per the protocol enclosed) at CIMR, AIIMS and Dayananda Medical College and Hospital, Ludhiana over a period of six months. During the study duration, the subjects will be invited to CIMR and Dayananda Medical College and Hospital, Ludhiana for the contact classes. There will be 8 continuous supervised sessions of 45 minutes each in the first two weeks and after which during the non-contact period the patients are advised to practice the same at home for 45 minutes each day, at least 5 days a week for next 6 months following randomization. Each session will have a pre-planned curriculum that will be progressively more challenging and which will facilitate adherence and secure repeatability of the intervention. A log book and picture based booket which will include yoga asanas that will be given to all recruited participants to follow their practice at home including duration and time of practice. Further, biweekly calls and video conferencing will be arranged to ensure their practice at home. A formal training programme for yoga therapists will be developed and delivered by CIMR. Retreat training will be offered in a similar manner by CIMR in every 6 months to ensure same practice in both the centres. CIMR will routinely monitor the performance of the yoga therapists, so as to improve the performance of the yoga therapists thereby improving the quality of delivery of the Intervention package.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients of all genders and age between 18-70 years.
2. Patients from Delhi NCR for study settings in Delhi.
3. Medical history which is compatible with OSA and AHI more than 15 per hour.
4. Availability of time to include physical activity in their daily routine and to come for the contact classes and investigations as per the protocol.
5. Not been engaged in regular yoga practice or any other alternative medicine for the same desired effect.
 
 
ExclusionCriteria 
Details  1. Patient’s refusal for Polysomnography.
2. Patients on CPAP.
3. Patients with a well-documented chronic history of congestive heart failure, chronic renal failure or chronic liver failure.
4. Patients having very severe hypoxemia (oxygen saturation <80% for >10% of recording time).
5. Pregnancy
6. Morbid obesity, Hypothyroidism
7. Patients underwent any metabolic surgery
8. Recent trauma to upper respiratory tract
9. Patients on systemic corticosteroid treatment
10. Inability to perform yoga exercises due to orthopaedic or musculoskeletal problems.
11. Patients currently participating in any other clinical trials in the same hospital or any other sites.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Apnoea hypopnea index
2. Oxygen desaturation index (ODI)
3. Heart Rate Variability (HRV) 
Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Stress and Inflammatory biomarkers  Baseline,at 3 months, at 6 months, and at 12 months from baseline 
Neuropsychological Evaluation Screening Tool (NEST) and Hindi Mental Status Examination (HMSE)  Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline 
Wechsler Memory Scale- III (WMS III) Indian Edition  Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline 
The Pittsburgh Sleep Quality Index (PSQI)  Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline 
Hamilton’s Depression Questionnaire (HAM-D)  Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline 
The Hamilton Anxiety Rating Scale (HAM-A)  Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline 
WHO QoL BREF questionnaire  Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline 
General metabolic parameters  Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   02/04/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE AS OF NOW 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The current study will be a multi-centric, single blinded, parallel group, randomized control trial with four assessment point i.e. Baseline, after 2 weeks, 3 months, 6 months and 12 months. The study will be conducted at two centers i.e. the Dayananda Medical College and Hospital, Ludhiana and Center for Integrative Medicine and Research (CIMR), AIIMS, New Delhi. The participants will be screened and all consenting participants will be recruited from outpatient services of neurology and pulmonary medicine department and from sleep study lab of Dayananda Medical College and Hospital, Ludhiana, after which they will be randomly divided into two groups with an allocation ratio of 1:1. All patients will be assessed for primary and secondary outcomes which include general metabolic measures and inflammatory biomarkers along with neuropsychological measures such as depression, anxiety, memory and QoL at baseline followed by assessments at 2 weeks, 3 months, 6 months and 12 months from baseline. The intervention group will receive the intervention (as defined below) whereas the control will continue to receive standard care at each of the center. 
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